FDA Product Code BTM: Ventilator, Emergency, Manual (resuscitator)
Leading manufacturers include Puritan Bennett Corp., Vital Signs, Inc. and Respironics, Inc..
209
Total
209
Cleared
124d
Avg days
1976
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg
155d
recently vs 123d historically
FDA 510(k) Cleared Ventilator, Emergency, Manual (resuscitator) Devices (Product Code BTM)
209 devices
Cleared
Nov 24, 2025
The BAG manual resuscitator and accessories
Laerdal Medical AS
Anesthesiology
180d
Cleared
Apr 25, 2025
butterflyBVM
Compact Medical, Inc.
Anesthesiology
130d
Cleared
Mar 18, 2023
EOlife®
Archeon
Anesthesiology
267d
Cleared
Aug 18, 2022
Sotair Device
Safe Bvm Corporation
Anesthesiology
339d
Cleared
Aug 26, 2021
Disposable Manual Resuscitator
Xiamen Compower Medical Tech. Co., Ltd.
Anesthesiology
205d
Cleared
Dec 07, 2018
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
Flexicare Medical Limited.
Anesthesiology
175d
Cleared
May 11, 2018
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
Foremount Enterprise Co., Ltd.
Anesthesiology
431d
Cleared
Aug 29, 2016
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
Ambu A/S
Anesthesiology
329d
Cleared
Jan 28, 2011
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
Ambu A/S
Anesthesiology
121d
Cleared
Apr 20, 2007
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
Ohmeda Medical
Anesthesiology
85d
Cleared
Dec 23, 2005
AMBU MARK IV RESUSCITATOR
Ambu A/S
Anesthesiology
44d
Cleared
Dec 20, 2005
AMBU MARK IV BABY RESUSCITATOR
Ambu A/S
Anesthesiology
41d
Cleared
Feb 07, 2003
NELLCOR INDGO MANUAL RESUSCITATOR
Nellcor Puritan Bennett, Inc.
Anesthesiology
112d
Cleared
Mar 25, 1998
DMR PLUS DISPOSABLE MANUAL RESUSCITATOR
Nellcor Puritan Bennett, Inc.
Anesthesiology
196d
Cleared
Dec 02, 1997
OHMEDA INFANT RESUSCITATION SYSTEM
Ohmeda Medical
Anesthesiology
243d
Cleared
Sep 03, 1997
ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP
Davis & Geck, Inc.
Anesthesiology
89d
Cleared
Jun 13, 1997
INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
Instrumentation Industries, Inc.
Anesthesiology
88d
Cleared
Apr 26, 1996
DMR/CO2 COMBO KTI
Nellcor Puritan Bennett, Inc.
Anesthesiology
85d
Cleared
Jan 05, 1995
RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE
Respironics, Inc.
Anesthesiology
462d
Cleared
Dec 12, 1994
PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR)
Puritan Bennett Corp.
Anesthesiology
97d
Cleared
May 06, 1994
BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS
Respironics, Inc.
Anesthesiology
87d
Cleared
Dec 14, 1993
BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR
Respironics, Inc.
Anesthesiology
104d
Cleared
May 28, 1992
MODIFICATION PURITAN-BENNETT INFANT PM2
Puritan Bennett Corp.
Anesthesiology
29d
Cleared
Feb 27, 1992
PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED
Puritan Bennett Corp.
Anesthesiology
20d
About Product Code BTM - Regulatory Context
510(k) Submission Activity
209 total 510(k) submissions under product code BTM since 1976, with 209 receiving FDA clearance (average review time: 124 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA 510(k) Review Time - BTM Product Code
Recent submissions under BTM have taken an average of 155 days to reach a decision - up from 123 days historically. Manufacturers should account for longer review timelines in current project planning.
BTM devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →